Generic Cymbalta ( Duloxetine )

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Cymbalta is a serotonin and norepinephrine reuptake inhibitor (SNRI) used to treat major depressive disorder, generalized anxiety disorder, and nerve pain associated with diabetic peripheral neuropathy. It is also approved for fibromyalgia and chronic musculoskeletal pain in adults. The medication works by increasing the levels of serotonin and norepinephrine in the brain and spinal cord, which helps improve mood and dampen pain signals.
The usual starting dose for depression and generalized anxiety disorder is 30 mg once daily for one to two weeks, then increased to 60 mg once daily. For diabetic nerve pain and fibromyalgia, treatment often starts at 30 mg daily and targets 60 mg daily. The maximum recommended dose is 120 mg per day, though doses above 60 mg have not been shown to provide extra benefit for depression.
The administration form is delayed-release capsules containing 20 mg, 30 mg, 40 mg, or 60 mg of duloxetine hydrochloride. The capsules must be swallowed whole. Do not open, crush, chew, or sprinkle the contents on food.
Cymbalta does not work overnight. Improvements in sleep, appetite, and energy may appear within the first two weeks, but the full benefit for mood and anxiety usually takes four to eight weeks of steady dosing. For nerve pain, the effect may take several weeks to build.
Alcohol should be avoided during treatment. It adds to the drowsiness and dizziness that duloxetine can cause, and heavy drinking increases the risk of liver damage.
The most common side effects are nausea, dry mouth, drowsiness, fatigue, and constipation. Sexual side effects such as decreased libido or difficulty reaching orgasm are also common.
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Common Use Cymbalta

Duloxetine is a balanced serotonin and norepinephrine reuptake inhibitor. It blocks the reuptake of both neurotransmitters at nerve endings, which increases their availability in the synaptic cleft. This dual action is thought to underlie its benefits for mood, anxiety, and pain. Duloxetine is the active ingredient in Cymbalta and is also available as generic duloxetine. Health Canada has approved duloxetine for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain in adults. It is not approved for use in children or adolescents under 18 years of age for any indication. Duloxetine is sometimes prescribed off-label for stress urinary incontinence in women and for chemotherapy-induced peripheral neuropathy, though these uses are not formally approved in Canada.

Basic Cymbalta Information

• INN (International Nonproprietary Name): Duloxetine hydrochloride
• Brand names available in Canada: Cymbalta® (Eli Lilly Canada Inc.); generics include ACCEL-Duloxetine (Accel Pharma Inc.), AG-Duloxetine (Angita Pharma Inc.), APO-Duloxetine (Apotex Inc.), Auro-Duloxetine (Auro Pharma Inc.), BIO-Duloxetine (Biomed Pharma), Jamp-Duloxetine (Jamp Pharma Corporation), MINT-Duloxetine (Mint Pharmaceuticals Inc.), NRA-Duloxetine (Nora Pharma Inc.), Sandoz Duloxetine (Sandoz Canada Inc.), Teva-Duloxetine (Teva Canada Limited), and others
• ATC Code: N06AX21
• Forms and dosages: Delayed-release capsules – 20 mg, 30 mg, 40 mg, and 60 mg. The Cymbalta brand is marketed in Canada in 30 mg and 60 mg strengths. Generic duloxetine is available in all four strengths.
• Manufacturers in Canada: Eli Lilly Canada Inc. (Cymbalta, DIN 02301482 for 30 mg, DIN 02301490 for 60 mg; both cancelled post market on 2024-09-25, but generic duloxetine remains available). Generic duloxetine is manufactured by Apotex Inc., Teva Canada Limited, Sandoz Canada Inc., Mint Pharmaceuticals Inc., Jamp Pharma Corporation, Angita Pharma Inc., Auro Pharma Inc., Biomed Pharma, Nora Pharma Inc., Accel Pharma Inc., and others.
• Registration status in Canada: Approved by Health Canada. Cymbalta brand DINs 02301482 (30 mg) and 02301490 (60 mg) are cancelled post market as of 2024-09-25, but generic duloxetine delayed-release capsules remain approved and marketed under multiple DINs, including 02436655 (Auro-Duloxetine 60 mg), 02481952 (Duloxetine Aliamed 30 mg), and 02490889 (Duloxetine, Sanis Health, 30 mg, status dormant).
• OTC / Rx classification: Prescription only (Rx) – not legally sold over-the-counter in Canadian pharmacies

Dosage & Direction

Take Cymbalta exactly as your doctor prescribes. Swallow the capsule whole with or without food. Food may help reduce early nausea. Do not open, crush, chew, or sprinkle the contents on food or mix them with liquids, because the delayed-release coating protects the drug from being released too quickly. For major depressive disorder, the usual starting dose is 40 mg to 60 mg per day, taken once daily or as 30 mg twice daily. The target dose for acute treatment is 40 mg to 60 mg per day, and maintenance treatment is typically 60 mg per day. The maximum dose is 120 mg per day, but there is no evidence that doses above 60 mg per day provide additional benefit for depression. For generalized anxiety disorder in adults, the starting and target dose is 60 mg once daily. Older adults and pediatric patients aged 7 to 17 years start at 30 mg once daily. For diabetic peripheral neuropathic pain and fibromyalgia, the starting dose is 30 mg once daily, with a target of 60 mg once daily. The maximum for these indications is 60 mg per day. If you have liver or kidney problems, your doctor may adjust your dose. Do not stop taking Cymbalta suddenly without talking to your doctor. Stopping abruptly can cause withdrawal symptoms such as nausea, dizziness, insomnia, irritability, and "electric-shock" sensations. Your doctor will taper the dose gradually over at least one to two weeks, or longer if needed.

Precautions

Cymbalta carries a boxed warning about an increased risk of suicidal thoughts and behaviours in pediatric and young adult patients taking antidepressants. Close monitoring is required, especially during the first few weeks of treatment or after dose changes. If you or someone you care for notices worsening mood, new or increased thoughts of self-harm, or unusual behaviour changes, get help immediately. Duloxetine can cause serotonin syndrome, a potentially life-threatening condition caused by too much serotonin in the body. The risk is higher when duloxetine is taken with other serotonergic drugs, including MAO inhibitors, other SNRIs, SSRIs, tricyclic antidepressants like clomipramine or amitriptyline, triptans, tramadol, buprenorphine, and St. John's wort. Symptoms include agitation, confusion, rapid heartbeat, muscle rigidity, and sweating. Stop the medication and seek emergency care if these occur. Duloxetine can cause liver injury, including hepatic failure, which has sometimes been fatal. Do not use Cymbalta if you have substantial alcohol use or evidence of chronic liver disease. Stop the medication and contact your doctor if you develop jaundice, dark urine, or other signs of liver dysfunction. Duloxetine can cause orthostatic hypotension, falls, and syncope, especially early in treatment and in older adults. Move slowly when getting up from a sitting or lying position. The medication can raise blood pressure and heart rate. Your doctor should check your blood pressure before you start treatment and periodically during treatment, especially if you have a history of hypertension or heart disease. Duloxetine can increase the risk of bleeding, especially when taken with aspirin, NSAIDs, warfarin, or other anticoagulants. Tell your doctor if you take any of these medications. The medication can cause hyponatremia, especially in older adults and people taking diuretics. Symptoms include headache, difficulty concentrating, memory problems, confusion, and weakness. Duloxetine can cause urinary hesitation or retention. Tell your doctor if you have difficulty urinating. Cymbalta should be used with caution in patients with a history of seizures. Duloxetine is not recommended during pregnancy unless the benefit clearly outweighs the risk. It can cause withdrawal symptoms in a newborn if used in the third trimester. It passes into breast milk, so breastfeeding is not recommended without medical advice. Women who could become pregnant should discuss the risks and benefits with their doctor. Duloxetine should not be used in children under 7 years of age. Older adults may be more sensitive to the side effects and may need lower doses. Tell your doctor if you have liver or kidney problems, as dose adjustments may be needed. Duloxetine can cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Contraindications

Do not take Cymbalta if you have had an allergic reaction to duloxetine or any of the inactive ingredients in the capsule. Cymbalta is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs), including phenelzine, tranylcypromine, and moclobemide. Do not start an MAOI within 14 days of stopping Cymbalta, and do not start Cymbalta within 14 days of stopping an MAOI. This combination can cause a life-threatening condition called serotonin syndrome. Duloxetine is contraindicated in patients with uncontrolled narrow-angle glaucoma, because it can raise intraocular pressure. Do not take Cymbalta if you have severe liver impairment. The medication should not be used during pregnancy or breastfeeding unless specifically directed by a doctor. Duloxetine is not approved for use in children under 7 years of age for generalized anxiety disorder, and it is not approved for major depressive disorder in children under 18 years of age. If you are unsure whether any of these apply to you, check with your doctor or pharmacist.

Possible Side Effects

More than 10% of people experience nausea, dry mouth, drowsiness, fatigue, and constipation. Other common side effects include decreased appetite, insomnia, dizziness, sweating, and blurred vision. Sexual side effects such as decreased libido, erectile dysfunction, and difficulty reaching orgasm are common but often not discussed. These effects are often most noticeable when starting treatment or increasing the dose, and they may fade as your body adjusts. Serious side effects require immediate medical attention. Serotonin syndrome presents with agitation, confusion, rapid heartbeat, muscle rigidity, and sweating. Liver injury can cause jaundice, dark urine, and abdominal pain. Orthostatic hypotension can cause fainting. Hyponatremia can cause headache, confusion, and weakness. Increased bleeding risk can cause easy bruising or unusual bleeding. Severe allergic reactions, including rash, hives, swelling of the face or throat, and difficulty breathing, need emergency care. If you develop any of these serious effects, stop the medication and seek medical help right away. Antidepressants, including Cymbalta, may increase suicidal thoughts or behaviour, especially in young people. If you notice worsening mood or new thoughts of self-harm, contact your doctor immediately. Discontinuation syndrome can occur if the medication is stopped suddenly, causing nausea, dizziness, insomnia, irritability, and "electric-shock" sensations.

Drug Interaction

Cymbalta interacts with several medications. MAO inhibitors are strictly contraindicated and must not be used with duloxetine. Other serotonergic drugs, including other SNRIs, SSRIs, tricyclic antidepressants like clomipramine and amitriptyline, triptans, tramadol, buprenorphine, pethidine, and St. John's wort, can increase the risk of serotonin syndrome. Duloxetine is a moderate inhibitor of CYP2D6. It can increase the levels of drugs metabolized by this enzyme, including risperidone, tricyclic antidepressants (nortriptyline, amitriptyline, imipramine), flecainide, propafenone, and metoprolol. Your doctor may need to adjust the dose of these medications. Duloxetine does not significantly affect the pharmacokinetics of theophylline, a CYP1A2 substrate. It does not induce CYP3A activity. Caution is advised when duloxetine is combined with oral anticoagulants or antiplatelet agents, due to a potential increased risk of bleeding. An increase in INR has been reported when duloxetine is given with warfarin. Antacids containing aluminum and magnesium, and famotidine, do not significantly affect the absorption of duloxetine. Tell your doctor and pharmacist about every medication you take, including over-the-counter products, vitamins, and herbal supplements.

Missed Dose

If you miss a dose of Cymbalta, take it as soon as you remember. If it is almost time for your next dose, skip the missed one and continue with your regular schedule. Do not take two doses at once to make up for a missed one. If you miss several doses in a row, contact your doctor before restarting. Missing doses can cause your symptoms to return, so try to take the medication at the same time each day.

Overdose

Overdose with Cymbalta can cause drowsiness, nausea, vomiting, fast heart rate, and tremor. In severe cases, it can cause serotonin syndrome, seizures, and changes in heart rhythm. There is no specific antidote. Treatment is supportive and may include activated charcoal if the overdose was recent, intravenous fluids, and monitoring of vital signs. Contact a poison control centre or go to an emergency department immediately if you or someone else has taken too much. Do not try to manage an overdose at home.

Storage

Store Cymbalta capsules at room temperature between 15 and 30 degrees Celsius (59 and 86 degrees Fahrenheit). Keep the container tightly closed and protect it from light and moisture. Do not store in the bathroom or near a sink. Keep out of reach of children and pets. Do not use after the expiry date on the label. Dispose of unused medication according to local guidelines. Do not flush duloxetine down the toilet or pour it down the sink.

Disclaimer

We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

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